FDA Radiology AI Devices

CerebralGo Plus is a software package designed for trained medical professionals to view and process CT Angiography images of the head and neck. It helps visualize large vessels from adult CTA scans to support clinical decisions, although it is not intended for primary diagnostic use. The software integrates with standard DICOM-compliant imaging devices and hospital systems to facilitate image management and processing.

Ultrasound System 2300 is a mobile, software-controlled diagnostic ultrasound system designed for a wide range of clinical applications including fetal, abdominal, pediatric, neuro, cardiac, and musculoskeletal imaging among others. It supports multiple ultrasound modes such as B-Mode, Doppler, Elastography, and Contrast Imaging to assist qualified healthcare professionals in imaging and guiding puncture and biopsy procedures, thereby improving diagnostic confidence and procedural accuracy.

The SKOUT system is an AI-powered software tool that helps gastroenterologists detect potential colorectal polyps in real time during colonoscopy procedures. By providing visual markers on the colonoscopy video feed, it aids trained specialists in identifying polyps that might be missed, supporting better colorectal cancer screening and surveillance.

Limbus Contour is a software tool that automatically segments CT and MRI images to help radiation oncologists, dosimetrists, and medical physicists create precise contours of healthy anatomical structures. These contours are used as inputs for radiation treatment planning, improving accuracy and efficiency in therapy. The software integrates with existing treatment planning systems and image viewers, assisting in contour creation, modification, and management without displaying images directly.

AI-Rad Companion (Cardiovascular) is a software product that uses AI and deep learning to analyze previously acquired chest CT images, providing quantitative and qualitative assessments of cardiovascular structures like the heart and aorta. It helps clinicians by automating segmentation, volume measurement, calcium quantification in coronary arteries, and diameter measurements of the aorta, thus supporting accurate and efficient cardiovascular disease evaluation.

Contour ProtégéAI is a medical imaging software accessory designed to assist trained medical professionals by automatically creating anatomical contours on CT and MR images using machine learning. It helps in radiation therapy planning by segmenting various body structures, including the prostate and pelvic organs, enabling quantitative analysis, adaptive therapy, and patient follow-up. Results generated by the AI can be reviewed and edited to ensure accuracy.

The Ingenia series MR Systems by Philips Medical Systems Nederland B.V. are advanced MRI devices that produce detailed cross-sectional images and spectra of the head, body, and extremities. Utilizing strong magnetic fields and radio signals, these systems aid physicians in diagnosing diseases, planning treatments, and guiding minimally invasive procedures by providing high-quality images. The new Precise Image software feature enhances image quality by employing deep learning to improve sharpness and reduce noise and artifacts, facilitating better clinical assessment.

Annalise Enterprise CTB Triage Trauma is an AI-powered software that assists clinicians by automatically analyzing brain CT scans to identify signs of acute hemorrhages. It helps prioritize studies in the workflow to ensure patients with urgent findings are reviewed faster, improving triage and clinical efficiency. The system integrates with existing imaging management systems and does not provide standalone diagnostic decisions but supports clinicians in managing their workload.

The Butterfly iQ/iQ+ Ultrasound System is a portable, handheld ultrasound device that helps healthcare professionals visualize and measure anatomical structures and fluids in both adult and pediatric patients. It supports multiple clinical applications including lung, cardiac, abdominal, and musculoskeletal imaging. The system integrates AI-powered software called Auto B-line Counter that automatically detects and counts B-lines in lung ultrasound images, aiding clinicians in diagnosing and monitoring lung conditions.

Formus Hip is a preoperative planning software designed to assist orthopedic surgeons by automatically generating 3D models of the hip from CT scans and overlaying digital representations of hip implants. It uses AI algorithms for image segmentation and statistical shape modeling, helping clinicians plan hip replacement surgeries more effectively by customizing implant fitting interactively and producing printable surgical plans.